Improving the management of open tibia fractures, Malawi

Abstract Objective To assess the impact of an open fracture intervention bundle on clinical management and patient outcomes of adults in Malawi with open tibia fractures. Methods We conducted a before-and-after implementation study in Malawi in 2021 and 2022 to assess the impact of an open fracture intervention bundle, including a national education course for clinical officers and management guidelines for open fractures. We recruited 287 patients with open tibia fractures. The primary outcome was a before-and-after comparison of the self-reported short musculoskeletal function assessment score, a measure of patient function. Secondary outcomes included clinical management; and clinician knowledge and implementation evaluation outcomes of 57 health-care providers attending the course. We also constructed multilevel regression models to investigate associations between clinical knowledge, patient function, and implementation evaluation before and after the intervention. Findings The median patient function score at 1 year was 6.8 (interquartile range, IQR: 1.5 to 14.5) before intervention and 8.4 (IQR: 3.8 to 23.2) after intervention. Compared with baseline scores, we found clinicians’ open fracture knowledge scores improved 1 year after the intervention was implemented (mean posterior difference: 1.6, 95% highest density interval: 0.9 to 2.4). However, we found no difference in most aspects of clinicians’ open fracture management practice. Conclusion Despite possible improvement in clinician knowledge and positive evaluation of the intervention implementation, our study showed that there was no overall improvement in clinical management, and weak evidence of worsening patient function 1 year after injury, after implementation of the open fracture intervention bundle.


Introduction
Economic growth, urbanization and increased road vehicle use have led to a rapid rise in the rates of road traffic incidents in low-income countries. 1Open fractures are increasingly common following such incidents.These can cause substantial complications and disability, including infection, non-union of fractured bones, amputation and poor function. 2Standardized treatment includes antibiotics, debridement, early stabilization and wound coverage. 3n high-income countries, the implementation of set standards for managing open fractures has improved care quality and reduced the need for surgeries. 4Whether similar improvements can occur in low-income countries with the implementation of locally adapted guidelines remains unknown. 5alawi, a low-income country in south-eastern Africa, has one of the highest rates of road traffic deaths in the world. 1 In 2017, Malawi's gross domestic product was 8.3 billion United States dollars (US$) and its gross national income per capita was US$ 620.6 Donors contributed to 55% of the Malawian health ministry's budget during 2022-2023.This reliance on donations raises concerns over the capacity to increase physical access to health facilities across the country.7 With only 14 orthopaedic surgeons for a population of 20 million (in 2021), most fracture care in Malawi is provided by orthopaedic clinical officers (non-physicians who undergo 3 years' training towards an orthopaedic diploma).8 In district (secondary) hospitals, such orthopaedic clinical officers predominantly provide non-operative care; tertiary hospitals on the other hand are staffed by orthopaedic surgeons and are therefore able to provide operative care.8 Most trauma and fracture interventions in low-and middle-income countries only report improvement in knowledge and behaviour -to date there has been very little evidence for whether this translates into improvement in clinical processes and patient outcomes.11 However, it should be noted that implementation of interventions such as the checklist have led to a reduction in mortality in low-and middle-income countries.12 Our primary aim was to evaluate patient function 1 year after an open tibia fracture before and after the implementation of a quality improvement intervention.Our secondary aim was to identify barriers and facilitators

Study site
The hospitals included two tertiary hospitals (Queen Elizabeth Central Hospital and Kamuzu Central Hospital) and four district hospitals (Dedza District Hospital, Ntcheu District Hospital, Balaka District Hospital and Machinga District Hospital).

Study population
Between February 2021 and March 2022, we recruited patients who were 18 years or older and had open tibia fractures classified as Arbeitsgemeinschaft für Osteosynthesefrage Foundation/Orthopaedic Trauma Association class 42. 15 The Gustilo classification of each fracture 16 was recorded by the most senior surgeon or orthopaedic clinical officer at each site during debridement.Sex was reported by patients and recorded by trained research assistants.
Clinical knowledge and implementation evaluation was captured on health-care providers that attended the Malawi Orthopaedic Association's annual general meetings on 23-24 September 2021 and 23 September 2022.

Components of the bundle
The quality improvement intervention for open fractures (hereafter referred to as the intervention or the intervention bundle) consisted of core and adaptable components (Box 1).All intervention bundle costs (i.e.development, materials, venue fees, transportation and allowances) were funded by international donors and, in 2019 the cost of the whole intervention totalled to US$ 26 500.

Intervention bundle development
As part of the implementation strategies 17 to bring all relevant stakeholders together, two consensus groups (consisting of expert Malawian orthopaedic clinical officers, orthopaedic surgeons and international orthopaedic teaching faculty) were convened 2 years before the implementation to agree on 17 guidelines for open fracture management.Additionally, one year before the implementation, the stakeholders agreed on the material and methods to be included in a training course on open fracture management. 5,18Although the expert groups helped create the quality improvement intervention bundle, no implementation material was distributed to clinical officers or the hospital management team before the implementation period.

Implementation
The intervention bundle was introduced into clinical practice midway through the prospective cohort study, during 23-24 September 2021.

Assessment of patient function
Patients reported their musculoskeletal function at baseline (asking participants to report their pre-injury score) and 6 weeks, 3 months, 6 months and 1 year after injury, using the short musculoskeletal functional assessment questionnaire.This assessment provides a dysfunction score, which ranges from 0 (no functional impairment) to 100 (severe functional impairment). 19,20

Assessment of clinical knowledge
Health-care providers taking the open fracture course completed an online questionnaire at three timepoints: at the start of the course; immediately after taking the course; and 1 year after taking the course.The questionnaire included questions relating to the participants' demographic characteristics plus 20 knowledge-based questions on the open fracture standards and guidelines.This questionnaire also contained questions regarding implementation evaluation outcomes, which followed Proctor's framework and included the acceptability score, appropriateness score, feasibility score and normalization (understanding/ opinion) questionnaire. 21,22

Adaptable components:
• Dissemination of guidelines via posters in all the primary and secondary centres that may refer to tertiary centres.• In addition to the above, sites were visited to select referral centres for education and training to enhance the implementation of the protocol.Visits and training were undertaken by local multidisciplinary members and the principal investigator.• Health-care telephone contacts were shared to improve communication of referrals to tertiary centres.• Feedback for the health-care professionals was offered in the first 3 months after the course on pre-and post-debridement photos.

Assessment of clinical management
Trained research assistants documented treatment characteristics based on information in medical notes during the initial hospital admission using electronic tablets and secure servers.

Statistical analysis
Our target sample size for the primary outcome (patient function) was 160 participants (80 before and 80 after implementation of the intervention).This sample size would provide 80% power to detect a 20% variance in the short musculoskeletal function assessment index score before the intervention bundle was implemented compared with after, with α of 0.01; allowing for 20% loss to follow-up.We planned to continue recruitment until the end of the study period (1 year) even if we exceeded our target.We compared baseline demographics and clinical management for patients with open tibia fractures before and after implementation of the intervention bundle using two comparative statistical tests: Kruskal-Wallis and χ2.
To investigate trajectories over time in patient function, in clinical knowledge, and in implementation evaluation following implementation of the open fracture interventional bundle, we constructed Bayesian multilevel regression models, with inference drawn using Markov chain Monte Carlo sampling.
For functional outcomes we fitted a model for hospital setting and Gustilo grade to account for the fact that the open fracture guidelines are guided by setting (district or tertiary hospital) and injury severity (Gustilo grade).Models were fitted using the R brms package as an interface to CmdStanR in R (R Foundation, Vienna, Austria). 23We modelled short musculoskeletal function assessment scores and knowledge scores using a Gaussian distribution and an ordinal model for the implementation evaluation outcomes, which included participant-level random intercepts.We summarized posterior distributions to compare the effects before and after implementation of the interventional bundle, stratified by hospital setting and Gustilo classification on short musculoskeletal function assessment over 1 year.Similarly, using posterior distributions, we compared knowledge and implementation evaluation outcomes before, immediately after and 1 year after implementation of the intervention bundle.Code and data are available in our online respository. 24

Study population demographics
Baseline demographic characteristics of patients are outlined in Table 1.We recruited a total of 287 adult patients with open tibia fractures between February 2021 and March 2022: 162 patients were recruited before implementation of the open fracture intervention bundle and 125 patients after.Thirty-six (22%) preintervention patients and 27 (22%) postintervention patients received treatment in district hospitals.No differences were found in terms of age (P-value: 0.70), sex (P-value: 0.86) or Gustilo grading (P-value: 0.46) between the before and after groups.

Patient function
There was no difference in empirical median short musculoskeletal function assessment dysfunction scores at 1 year, 6.8 (interquartile range, IQR: 1.5 to 14.5) before intervention, compared to 8.4 (IQR: 3.8 to 23.2) after intervention.
There was weak evidence of worsening modelled short musculoskeletal function assessment score at 1 year for participants in district hospitals with Gustilo I/II injuries (mean posterior difference short musculoskeletal function assessment: 1.9; 95% confidence interval, CI: −0.2 to 4.4) and with Gustilo III injuries (mean posterior difference short musculoskeletal function assessment: 2.4; 95% CI: −0.3 to 5.5) (Fig. 1).
Similarly, there was weak evidence of worsening modelled short musculoskeletal function assessment score at 1 year for participants in tertiary hospitals with Gustilo I/II injuries (mean posterior difference short musculoskeletal function assessment: 1.7; 95% CI: 0.2 to 3.6) and with Gustilo III injuries (mean posterior difference short musculoskeletal function assessment: 2.4; 95% CI: 0.2 to 4.7).

Clinical knowledge
A total of 57 candidate health-care providers attended the open fracture course; their demographics are summarized in the online repository. 24ur results suggest that open fracture knowledge scores (out of 20) might have improved both immediately after the course (posterior mean: 17.1, 95% credible interval: 14.6 to 18.25) and 1 year after the course (posterior mean: 14.8, 95% credible interval: 13.9 to 15.7) compared to before the course (posterior mean: 13.4, 95% credible interval: 11.2 to 14.6), however, the credible intervals overlap (Fig. 2).

Clinical management
Results of documentation and clinical management (clinical processes) by the health-care providers are summarized in Table 2.

Discussion
Our study shows that while implementation of the open fracture interventional bundle in district hospitals might have led to a sustained improvement in clinical knowledge and positive evaluation of the intervention, there was little overall change in clinical management and weak evidence of worsening patient function.For example, we show that only 11 of 27 patients in district hospitals with open fractures had debridement under spinal or general anaesthesia after implementation of the intervention bundle.
One reason for this lack of change in management and patient outcome may be inadequate hospital facilities

Research
and resources, a recognized challenge for implementation studies. 25,26Challenges relating directly to implementing open fracture guidelines in settings such as government hospitals in Malawi include a severe lack of resources such as water, electricity, radiography, basic orthopaedic equipment, anaesthesia and operating theatres. 27,28In addition, other specialities, such as obstetrics, might be prioritized over trauma operations. 29ossible explanations for the worsening of patient-reported function following treatment in tertiary hospitals in the post-intervention period could be increased infections during Malawi's wet season (November-March), or increased road traffic injuries during the Christmas holiday period due to more patients with injuries and delays to treatment. 30,31Solutions could include improving infection control in hospitals, increasing road safety awareness campaigns and strengthening law enforcement. 31hile better overall surgical care and better facilities and resources in district hospitals are needed to improve patient outcomes following trauma, Malawi faces challenges.The country is heavily dependent on donors, and to date development assistance for low-income countries has been heavily skewed towards communicable diseases; only 0.6% of funding has been allocated to injury and violence. 32Those challenges are combined with a rapidly increasing burden of injuries.While improving surgical care is undoubtedly costly (an estimated US$ 23 billion annual investment between 2015-2030 would be needed to reach safe levels of global surgical care), 33 the economic loss for people with surgical conditions is estimated to be much more, around US$ 12.3 trillion among low-and middle-income countries between 2015-2030. 34Therefore, substantial investment from government and donors in surgical care and road safety prevention will be required to reduce the disability from road-traffic injuries victims.
Other barriers to successful implementation could include health-care provider behaviour, task-shifting (when orthopaedic clinical officers are required to provide fracture care due to the low ratio of doctors per population in Malawi), poor supervision and lack of feedback from specialists. 26,33,35,36We found that after the intervention, only 39% (49/125) of health-care providers documented the timing of antibiotics, and only 23% (29/125) documented neurovascular status in the medical notes.Qualitative evidence from clinical officers in district hospitals in low-income countries, and informal discussions with clinical officers during our study suggest that poor motivation is also a barrier to the operative care of patients, which could partly be due to inadequate continuous education, poor career progression, and lack of supervision and accountability. 37 systematic review of approaches to motivate physicians and nurses in low-and middle-income countries found that studies that primarily focused on financial compensation either showed no or negative effects; interventions with a supervisory component, on the other hand, had mostly positive effects. 38Different supervision models for surgical care in low-and middleincome countries have been proposed, including managed surgical networks; 39 national accountability and monitoring programmes; 40 and regular in-person site visits by surgical specialists. 41Both the training of orthopaedic specialists and orthopaedic clinical officers are cost-effective and are required to improve supervision. 42,43Nevertheless, district hospitals should ideally establish referral pathways to tertiary hospitals where patients can access adequate expertise and resources to treat their complex injuries.
Despite the burden of injury rapidly worsening and task-shifting being common in many low-and middle-income countries, it is unclear if our identified barriers can be generalized to other lowand middle-income countries where other factors may come into play.For example, health-care systems in some low-and middle-income countries have higher physician-per-population ratios, with increased health-care resources, 44 than in Malawi; this difference could reduce the suggested barriers of poor hospital environment and lack of specialist supervision.Additionally in some countries, particularly in the Saharan belt, training of traditional bone setters might help reduce complications of open fracture care. 45he study has some limitations.First, 78% (224/287) of participants were from tertiary hospitals (which have permanent orthopaedic specialists); as such, the change in clinical process specific to district hospitals (which rely on orthopaedic clinical officers) might have been overshadowed.More participants from district hospitals may help detect a change in patient function after intervention.Second, health-care providers participating in our study were only recruited up to 6 months after the intervention period; it is possible that changes in implementation evaluation outcomes might take longer to translate into changes in clinical process and patient outcomes.While uncertainty intervals for knowledge and behaviour changes overlapped, our findings did demonstrate a strong trend towards improved knowledge after the course.Third, the before-and-after study design might have introduced confounders, selection bias, or been influenced by the Hawthorne effect (where participants change their behaviour in response to being observed). 46Finally, this study was conducted during the coronavirus disease 2019 (COVID-19) pandemic, which may have reduced monitoring in district hospitals and reduced theatre capacity (for example, due to anaesthesia redeployment to high-dependency units). 47urther studies aimed at investigating if an open fracture interventional bundle is effective in changing clinical processes and patient outcomes following open tibia fractures in Malawi (or in other low-and middleincome countries) should aim to recruit a greater number of participants from district hospitals over a longer period.Additional studies could focus on improving orthopaedic facilities and resources in hospital; improving orthopaedic clinical officer motivation; and encouraging teamwork between orthopaedic clinical officers and orthopaedic surgeons.
Future implementation studies could evaluate whether managed surgical networks, orthopaedic clinical officer accountability, and district hospital visits from orthopaedic surgeons might improve outcomes following open fractures in low-and middleincome countries.Training district health system managers in clinical governance may increase their monitoring evaluation skills in low-and middle-income countries.Meanwhile, financial loans to health-care workers to undertake training courses might be an effective way of improving training while also mitigating the loss of skilled orthopaedic personnel to other countries. 48n summary, our study shows that in Malawi, implementation of an open fracture interventional bundle did not improve functional outcomes for patients with an open tibia fracture, despite possible improvement in clinician knowledge.This result could be due to a severe lack of resources in hospital and/or poor supervision of health-care providers.Increases in injuries during the rainy season and public holidays may also have affected the study outcome.

Fig. 2 .
Fig. 2. Trends in knowledge scores of health-care providers attending an open fracture course, Malawi, 2021-2022

Core and adaptable components of the open fracture intervention bundle Core components:
Box 1.

Table 2 . Clinical process pre-and post-intervention for open tibia fractures, Malawi, 2021-2022
a Two patients were missing hospital setting or timing of intervention.b Within 12 hours for Gustilo II or III and within 24 hours for Gustilo I injuries (based on the open fracture guidelines). 5c Forty percent missing timing of debridement.d Debridement with inadequate anaesthetic occurred in district hospitals before referral to a tertiary hospital.e One participant from a district hospital was referred to a tertiary hospital for external fixation.Fig. 3. Implementation

evaluation outcome responses by health-care providers attending an open fracture course, Malawi, 2021-2022
Note: A total of 57 health-care providers attended the course.Estimated from a Bayesian multilevel item response model with nest effects for domains and items, and participant-level random effects.Bull World Health Organ 2024;102:255-264| doi: http://dx.doi.org/10.2471/BLT.23.290755Alexander T Schade et al.